Trastuzumab emtansine (Kadcyla®, Roche) has received FDA approval for adjuvant treatment of HER2-positive early breast cancer (eBC) in people with residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
The FDA rapidly reviewed and approved the application under the agency’s Real-Time Oncology Review and the Assessment Aid pilot programs, which led to an approval in just over 12 weeks.
The approval is based on results from the phase 3 KATHERINE study, an international, multicenter, two-arm, randomized, open-label trial showing that trastuzumab emtansine significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin (Genentech), as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment.
At three years, 88.3% of people treated with trastuzumab emtansine did not have a recurrence of breast cancer compared to 77.0% treated with Herceptin, an improvement of 11.3%.
The most common side effects were fatigue; nausea; increased blood levels of liver enzymes; musculoskeletal pain; bleeding; decreased platelet count; headache; numbness, tingling or pain in the hands or feet; and joint pain.
Trastuzumab emtansine is an antibody-drug conjugate (ADC) designed to deliver powerful chemotherapy directly to HER2-positive cancer cells, which could restrict damage to healthy tissue. The drug combines two anti-cancer properties joined by a stable linker: trastuzumab’s HER2-targeting properties and the chemotherapy agent DM1.
Source: Roche, May 6, 2019